Asterias Biotherapeutics (AST) Treats First AIS-A Spinal Cord Patient with Maximum AST-OPC1 Dosage
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Asterias Biotherapeutics, Inc. (NYSE: AST) announced that the first patient with complete (AIS-A) cervical spinal cord injury was successfully administered the highest dose of 20 million cells of AST-OPC1 (oligodendrocyte progenitor cells) in the SCiStar clinical trial at Santa Clara Valley Medical Center (SCVMC) in San Jose, CA. In addition, enrollment continues in the AIS-B 10 million cell cohort with a second patient now dosed.
Dose escalation to 20 million cells followed the Data Monitoring Committee (DMC) review of safety data from the prior 2 million cell and 10 million cell dose cohorts, and was based on AST-OPC1's continued favorable safety profile observed in the ongoing clinical study. The company recently presented positive early efficacy data from the 10 million cell cohort. These data reached the 6 month efficacy target within 3 months and suggested the emergence of a possible early dose response for AST-OPC1.
"We have been very encouraged by the early clinical efficacy and safety data for AST-OPC1, and we now look forward to evaluating the 20 million cell dose in complete cervical spinal cord injury patients," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "Based on extensive pre-clinical research, this is in the dosing range where we would expect to see optimal clinical improvement in these patients."
Stephen McKenna, MD, Chief of the Rehabilitation Trauma Center at SCVMC, said, "The early efficacy results presented in September from the 10 million cell AIS-A cohort were quite encouraging, and we're looking forward to seeing if those meaningful functional improvements are maintained through six months and beyond. We are also looking forward to seeing the results in patients from the higher 20 million cell AST-OPC1 dose, as well as results in the first AIS-B patients."
The trial results to date continue to support a positive safety profile for AST-OPC1. There have been no serious or unexpected adverse events related to AST-OPC1, the administration procedure or the accompanying short course of low-dose immunosuppression in any of the patients treated with AST-OPC1, including five patients in an earlier Phase 1 trial with neurologically complete thoracic SCI.
In September, Asterias reported positive early efficacy data for AST-OPC1 from five AIS-A patients that had been dosed with 10 million AST-OPC1 cells in the SCiStar study. While early in the study, by Day 90 of follow-up, all patients have shown at least one motor level of improvement and the efficacy target of 2 of 5 patients in the cohort achieving two motor levels of improvement on at least one side of their body was achieved. Patient improvements are being measured by the ISNCSCI neurological classification scale widely used to quantify functional status of patients with spinal cord injuries. As suggested by existing research in patients with complete cervical spinal cord injuries, a two motor level improvement is correlated with a significant increase in functional ability, as well as the ability for patients to care for themselves, since so many activities of daily living are dependent on arm and hand function [Steeves, et al, 2012].
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